Kornimate/medical-research-clean huggingface dataset:
endobesity® ii study: transpyloric shuttle® system for weight loss

Conditions: Obesity

Summary: the purpose of this clinical research trial is to study safety and effectiveness of the transpyloric shuttle system (tpss) for weight reduction in patients who are considered medically obese.


Eligibility criteria:
inclusion criteria: * male and female subjects between the ages of 22 to 60 * a bmi between 30.0 to 40.0 kg/m2, inclusive. subjects with a bmi of 30.0 kg/m2 to 34.9 kg/m2 are required to have one or more obesity-related comorbidities * history of obesity for at least 2 years, with history of failure of medically or commercially supervised weight loss program * \< 5% change in body weight for at least 3 months * negative pregnancy test, agree to be on birth control for the duration of participation * informed consent * willing and able to comply with study procedures exclusion criteria: * pregnancy or nursing * hormonal or genetic cause for obesity * prior history of any gi surgery or endoscopic intervention * chronic use of medications likely to contribute to weight gain or prevent weight loss * gastric or duodenal ulcers * positive for h. pylori * history of severe dyspepsia * gi tract motility disorders * history of inflammatory disease of gi tract, coeliac disease, pancreatitis, portal hypertension, cirrhosis, and/or varices * diabetes treated with insulin * hba1c \>7.5% * uncontrolled thyroid and adrenal gland disease or uncontrolled hypertension * history of certain cardiac events * localized or systemic infection * anemia * history of asthma likely to require systemic steroid therapy * autoimmune connective tissue disorders or immunocompromised * history of malignancy except non-melanoma skin cancer * continuous use of ulcerogenic medication * on anticoagulation or antiplatelet therapy * use of weight-loss medication * in other weight-loss program * unable to take proton pump inhibitor * abnormal laboratory values or ekg * inability to walk at least 0.8 kilometers per day * planned surgical procedure that can impact the conduct of the study * known allergy to any component materials in the tpss * smoker or user of nicotine product * substance abuse * severe, uncontrolled psychiatric illness * recent inpatient psychiatric treatment * moderate depression * bulimia nervosa or binge eating disorder * participation in another clinical study * employee or family member of sponsor or study staff * have any endoscopic exclusion criteria

Keywords: obesity weight loss device non-surgical endoscopic transpyloric shuttle tps
genicular artery embolization (gae) vs intra-articular corticosteroid injection for osteoarthritic knee pain.

Conditions: Osteoarthritis (OA) of the Knee

Summary: this study investigates genicular artery embolization (gae) as a minimally invasive alternative to ntra-articular corticosteroid injections (ia) or treating knee osteoarthritis (oa) pain. designed as a randomized controlled tria, the study compares pain relief effectiveness and safety between gae and ia over a 12-month follow-up. eligible participants are aged over 40 with symptomatic knee oa resistant to conservative treatment. primary outcomes focus on pain reduction (nrs score), while secondary measures include function, quality of life, imaging findings, and adverse events.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years 2. symptomatic knee pain, with numeric rating scale (nrs) ≥ 4. 3. insufficient or resistant to conservative treatment, including oral analgesics, physical therapy, intra-articular injections for at least 3 months, before the enrollment. 4. weight bearing x ray of knee: osteoarthritis of kellgren-lawrence grade 1, 2, or 3. exclusion criteria: 1. history of trauma in recent 6 months. 2. bleeding tendency. 3. poor renal function (serum creatinine \> 2.0 mg/dl). 4. pregnancy or breast-feeding. 5. severe peripheral arterial occlusive disease (paod). 6. local infections or inflammatory arthritis of knee. 7. rheumatoid arthritis or other rheumatological diseases. 8. prior knee surgeries (arthroscopic surgery, menisci repair, cruciate ligament reconstruction, arthroplasty of knee) due to knee pain. 9. malignancy 10. ecog \> grade 2 11. life expectancy less than 2 years. 12. any other condition related to the patient's health, regarded exclusionary in the opinion of the investigator.

Keywords: knee osteoarthritis genicular artery embolization imipenem/cilastatin intra-articular corticosteroid injection
carvedilol sr study for biomarkers from blood and urine and safety of in patients with heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: beta blockers have been used to reduce the mortality and heart failure rehospitalization in heart failure with reduced ejection fraction (hfref) patients in addition to acei/arb, mra, ivabradine and arni. however, the effective and safe medical therapy is not well established in heart failure with preserved ejection fraction (hfpef) yet. recent meta-analysis showed that beta blockers may also be beneficial for reducing the mortality and heart failure rehospitalization in hfpef like hfref. however, the clinical effect and safety of carvedilol have been largely unknown in hfpef. therefore, caymus hfpef is the exploratory study to assess the change of surrogate markers (ntprobnp, hstn) when treated with carvedilol sr vs. placebo in hfpef patients


Eligibility criteria:
inclusion criteria: 1. provision of informed consent prior to any study specific procedure 2. male or female, aged ≥ 19 years 3. patients with chronic hf (chronic heart failure) nyha (new york heart association classification) class ii-iv and preserved ef (ejection fraction)(lvef (left ventricular ejection fraction) \> 40 %) and elevated nt-probnp (n-terminal of the prohormone brain natriuretic peptide) \> 200 pg/ml for patients without af, or \> 600 pg/ml for patients with af, analysed at the central laboratory at visit 1 4. structural heart disease within 6 months prior to visit 1 using echocardiagraphy exclusion criteria: 1. myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke or tia (transient ischaemic attack) in past 90 days prior to visit 1 2. contraindication to beta blocker 3. heart transplant recipient or listed for heart transplant 4. hospitalization plan for pci, coronary artery bypass graft surgery, other cardiac invasive interventions (e.g. catheter ablation, pacemaker, crt, icd implantation) 5. acute decompensated hf (heart failure) 6. symptomatic hypotension or systolic blood pressure \< 100 mmhg) 7. patients with crcl \< 30 ml/min using creatinine-based ckd-epi equations 8. elevated liver enzymes (3 times over upper reference limit) or liver cirrhosis 9. symptomatic bradycardia or heart rate \< 60/min 10. allergy, adverse drug reaction, hypersensitivity to carvedilol 11. life expectancy \< 6 months (e.g. metastatic malignancy) 12. pregnancy, or women of childbearing age
testing a resilience intervention for individuals aging with multiple sclerosis (ms)

Conditions: Multiple Sclerosis

Summary: this study aims to test the efficacy of the everydaymatters multiple sclerosis (ms) program for individuals age 45 or older living with multiple sclerosis. the program involves a 6-week telephone-delivered program to promote resilience and happiness for individuals living with ms.


Eligibility criteria:
inclusion criteria: * 45 years of age * diagnosis of multiple sclerosis * regular access to the phone and internet * willing to join a moderated group on msconnection.org exclusion criteria: * under 45 years of age * no diagnosis of multiple sclerosis * no access to the phone or internet * unwilling to join moderated group on msconnection
optimizing recovery after reverse shoulder arthroplasty with a personalized mobile health application

Conditions: Shoulder Osteoarthritis

Summary: background: mobile health (mhealth) - the use of medical applications in healthcare settings - include tools that can support self-management after surgery and thereby contribute to early postoperative recovery. providing patients with timely and interactive information through mhealth is hypothesized to positively influence recovery after reverse shoulder arthroplasty (rsa). aim: the aim of this study is to determine the effectiveness of interactive and personalized information and rehabilitation protocol with a mobile application compared to generic information and generic rehabilitation protocol (standard care) on postoperative recovery in patients undergoing primary rsa. methods and analysis: a multicentre randomised controlled trial will be conducted in two dutch hospitals. in total 170 patients undergoing elective, primary rsa will be included. participants will be randomly allocated to one of the two groups on a 1:1 ratio. the intervention group will receive interactive postoperative information on a daily basis. the control group will receive standard care. the primary outcome is defined as functional recovery measured using the oxford shoulder score (oss) at 6 weeks. secondary outcomes are: pain, physical functioning, quality of life, length of stay, complications, treatment satisfaction and app use. the between group difference will be analysed using linear mixed-effects regression.


Eligibility criteria:
inclusion criteria: * adults undergoing elective reverse shoulder arthroplasty exclusion criteria: 1) do not own or are not able to operate a smart device; 2) are scheduled for revision surgery; 3) have a fracture as primary diagnosis; 4) an additional muscle transfer needs to be performed; or 5) are unable to read and understand the dutch language.

Keywords: reverse shoulder arthroplasty mhealth perioperative care rehabilitation
quantitative covid-19 sars-cov-2 antibody pre and post cardiopulmonary bypass

Conditions: Laboratory Assessment SARS-CoV-2 Antibody Levels Before and After Surgery for Patients Requiring Cardiopulmonary Bypass

Summary: this study is designed to compare the levels of sars-cov-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (cpb).

this study is designed to compare the levels of sars-cov-2 antibody prior to cardiopulmonary bypass and after cardiopulmonary bypass (cpb). during cpb the patients' blood volume is removed from the body and sent through the cpb machine. cpb consists of a pump (to keep blood moving) and oxygenator (to oxygenate blood). the oxygenator or cpb circuitry may effect antibody levels. in addition, patients on cpb experience hemodilution from blood transfusion and priming volume from the cpb circuit. hemodilution may effect antibody levels. prior to cpb, during standard of care lab drawn from standard of care arterial catheter, 0.5ml of plasma will be sent to the tjuh microbiology lab for roche elecsys anti-sars-cov-2 immunoassay for pre-cpb quantitative antibody testing. on morning of postoperative day 1, during standard of care lab draw from standard of care arterial catheter, 0.5ml of plasma will be sent to the tjuh microbiology lab for roche elecsys anti-sars-cov-2 immunoassay for post-cpb quantitative antibody testing. on morning of postoperative day 5, during standard of care lab draw, 0.5ml of plasma will be sent to the tjuh microbiology lab for roche elecsys anti-sars-cov-2 immunoassay for post-cpb quantitative antibody testing. if patient is discharged from the hospital prior to postoperative day #5, this immunoassay will be omitted.

Eligibility criteria:
inclusion criteria: * all patients presenting for elective cardiac surgery with the use of cardiopulmonary bypass that have received 2 or 3 doses of fda approved or emergency use authorization covid vaccine. exclusion criteria: * age \< 18. * patients with indeterminant history of vaccination schedule.
evaluation of a hearing device for transmitting sound to the inner ear

Conditions: Conductive Hearing Loss; Mixed Hearing Loss

Summary: a single center study evaluating the performance of an externally worn sound processor for a transcutaneous bone anchored hearing system using audiological outcomes measures such as aided thresholds and self-evaluation questionnaires.

bone conduction hearing systems use the body's natural ability to transfer sound through bone conduction. the sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. bone conduction devices currently on the market are divided into three types; transcutaneous direct drive, percutaneous (skin penetrating) direct drive and transcutaneous skin drive bone conduction devices. this evaluation focus on a sound processor used for a transcutaneous system.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form 2. adult subjects (18 years or older) 3. subjects implanted with an i1 implant 4. fluent in swedish exclusion criteria: 1. subjects who do not have the ability or are un-willing to follow investigational procedures/requirements, e.g., to complete questionnaires, according to investigator's discretion. 2. subject deemed unsuitable for any medical or other reason as judged by pi or medical responsible.
noga angiogenesis revascularization therapy: evaluation by radionuclide imaging - the northern trial

Conditions: Myocardial Ischemia

Summary: to demonstrate the clinical efficacy and safety of vascular endothelial growth factor(vegf165)when delivered by direct myocardial injection through the noga navigational catheter to improve myocardial perfusion in patients with severe angina pectoris for whom conventional pci or cabg are either not possible or not ideal.secondary objective will be to determine the effects of vegf gene therapy on angina symptoms, patient perceived quality of life and exercise capacity

a multicentre, double blind, placebo controlled trial to assess efficacy of vegf and promote myocardial angiogenesis in patients with ccs iii-iv angina symptoms,treated with maximal anti anginal medications who are not amenable to or not ideal candidates for conventional revascularization.

Eligibility criteria:
inclusion criteria: * canadian cardiovascular class iii-iv angina despite treatment with maximal medical therapy * lvef\>20% * ischemic defects on myocardial stress spect imaging exclusion criteria: * nyha\>2 * history of or diagnosis of age related macular degeneration, retinopathy * atrial fibrillation * primary valvular heart disease * evidence of or known history of cancer with in past 10 yea * uncontrolled hypertension * liability to receive dipyridamole * history or diagnosis of rheumatoid arthritis * recent mi(within 4 weeks) * important ilio-femoral peripheral vascular disease, limiting catheter access * history of unexplained gastrointestinal hemorrhage with the past 5 years * lv thrombus visualized by either echocardiography or contrast lv angiogram * other severe concurrent illnesses

Keywords: angiogenesis vegf
effects of low fat milk consumption on metabolic syndrome

Conditions: Metabolic Syndrome

Summary: this study aimed to investigate the effects of low-fat milk consumption on metabolic parameters and biomarkers related to inflammation, oxidative stress, and endothelial function in korean adults with metabolic syndrome.

a randomized, controlled, parallel, dietary intervention study was designed. subjects with metabolic syndrome and body mass index ≥23 kg/m2 were randomized to the low-fat milk group, which were instructed to consume 2 packs of low-fat milk per day (200 ml twice daily) for 6 weeks, and the control group was instructed to maintain their habitual diet. metabolic markers were evaluated at baseline and at the end of the study.

Eligibility criteria:
inclusion criteria: * subjects were enrolled if their body mass index (bmi) was ≥23 kg/m2 and they met the criteria for metabolic syndrome. exclusion criteria: * those who were allergic to milk; those who had a history of digestive disorder; those with a medical history of cardiovascular diseases, including coronary artery diseases, valvular heart diseases, heart failure, or stroke; those who had cancer in the past 5 years; those who were taking hypoglycemic agents for diabetes mellitus; those who had chronic disease such as renal failure or liver cirrhosis; and those with a hemoglobin a1c (hba1c) level ≥ 7% were excluded from the research. people who had a weight change \> 5% of the total weight within the past 3 months, those who had started taking or had changed their dose of anti-hypertensive agents or medications for dyslipidemia within the previous 1 month, those who had a newly diagnosed dyslipidemia requiring drug treatment, those who had taken steroids either orally or by injection within the previous 3 months, those who were pregnant or were expecting to become pregnant; and those who regularly consumed milk in quantities ≥ 200 ml per day at least 3 times a week on average were also excluded.

Keywords: low-fat milk metabolic syndrome lipid profile inflammation oxidative stress endothelial function
an study to examine the effect of coated suppositories on anal pressure in healthy subjects

Conditions: Fecal Incontinence

Summary: this is an open label, dose-finding, 2-parts study. approximately 6 subjects will be participating in this study. this study is composed of 2 parts: part 1 is a dose finding study. part 2 is a pharmacodynamic and pharmacokinetic study of an elected dose. a screening will be used to determine patients' suitability for inclusion in the trial. within one week after the screening visit, subjects who meet all inclusion criteria and none of the exclusion criteria will enter part 1 of the study, one day of dose escalation. during this part, patients will undergo rectal manometry to determine anal pressure at baseline. afterwards coated suppositories at various drug concentrations will be inserted and follow up manometries will be performed to determine response. patients that presented with an increase in rectal resting pressure without adverse events will enter the second part of the study. in this part, patients will be administered with a coated suppository, at a dose found at part 1 of the study to cause significant anal contraction. manometry studies will be performed before insertion (baseline) and at 1, 3 and 5 hours after insertion. blood levels for drug concentrations will be taken at times 0, 30, 60, 120, 180, 300 minutes after administration and rectal manometries will be done at times 0, 1, 3 and 5 hours after administration.


Eligibility criteria:
inclusion criteria: * signed written informed consent. * male or female subjects 18 to 55 years of age; exclusion criteria: * known allergy to the active drug or excipients. * pregnancy or lactation. * active cardiovascular or cerebrovascular disease including unstable angina, myocardial infarction, transient ischemic attacks/stroke, clinically significant arrhythmia, congestive heart failure, or cardiac valve abnormalities; * type 1 diabetes mellitus; * insulin treated type 2 diabetes mellitus; * renal insufficiency. * liver insufficiency. * malignant disease within 5 years of screening; * history of rectal surgery. * history of hiv, hepatitis b, hepatitis c. * has upon physical examination a rectal deformation or signs of rectal disease such as fissure, bleeding hemorrhoids, fistula, infection or space occupying lesion. * chronic use of medications with the exception of birth control pills.
leo 124249 ointment in the treatment of alopecia areata

Conditions: Alopecia Areata

Summary: this clinical trial attempts to investigate the efficacy and safety of leo 124249 ointment in the treatment of alopecia areata and the molecular disease mechanism and biomarkers.

the objectives of this clinical trial are to compare the efficacy of twice-daily topical leo 124249 30 mg/g ointment with leo 124249 ointment vehicle for 12 weeks in the treatment of hair loss in subjects with alopecia areata, to evaluate the safety of this treatment, to evaluate hair regrowth, to determine subject quality of life, and to explore disease mechanism and its biomarkers.

Eligibility criteria:
inclusion criteria: * subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial. * subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at visit 1 (screening) and visit 2 (day 1, baseline). * minimum 6 month duration of hair loss at visit 1 (screening). no upper limit time limit. * subject must accept to not cut hair in the treated scalp areas during the trial. exclusion criteria: * females who are pregnant or are breast feeding. * current signs of spontaneous hair regrowth. * diffuse type alopecia areata. * co-existing moderate to severe androgenic alopecia (norwood-hamilton stage iv-vi and ludwig stage ii and iii) * subjects with changed or expected changes in medication for thyroid disease within 6 month before visit 1 (screening) or during the trial. * systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).